IEC 60601-2-83:2019
(Main)Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
IEC 60601-2-83:2019 is applicable to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HOME LIGHT THERAPY EQUIPMENT, intended for use in the HOME HEALTHCARE ENVIRONMENT. HOME LIGHT THERAPY EQUIPMENT is typically used by a LAY OPERATOR.
The scope of this document includes all light sources except laser.
Appareils électromédicaux - Partie 2-83: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de luminothérapie à domicile
IEC 60601-2-83:2019 s'applique à la SÉCURITÉ DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS DE LUMINOTHÉRAPIE À DOMICILE conçus pour être utilisés dans l'ENVIRONNEMENT DES SOINS A DOMICILE. Les APPAREILS DE LUMINOTHÉRAPIE À DOMICILE sont généralement utilisés par un OPERATEUR NON SPECIALISTE.
Le domaine d'application du présent document comprend toutes les sources de lumière à l'exception des lasers.
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IEC 60601-2-83 ®
Edition 1.0 2019-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-83: Particular requirements for the basic safety and essential performance
of home light therapy equipment
Appareils électromédicaux –
Partie 2-83: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de luminothérapie à domicile
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IEC 60601-2-83 ®
Edition 1.0 2019-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-83: Particular requirements for the basic safety and essential
performance of home light therapy equipment
Appareils électromédicaux –
Partie 2-83: Exigences particulières pour la sécurité de base et les
performances essentielles des appareils de luminothérapie à domicile
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.60 ISBN 978-2-8322-6953-4
– 2 – IEC 60601-2-83:2019 © IEC 2019
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
201.1 Scope, object and related standards . 6
201.2 Normative references . 7
201.3 Terms and definitions . 8
201.4 General requirements . 10
201.5 General requirements for testing ME EQUIPMENT . 10
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 10
201.7 ME EQUIPMENT identification, marking and documents . 12
201.8 Protection against electrical HAZARDS from ME EQUIPMENT. 15
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 15
201.10 Protection against unwanted and excessive radiation HAZARDS . 15
201.11 Protection against excessive temperatures and other HAZARDS . 17
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 18
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 18
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 18
201.15 Construction of ME EQUIPMENT . 18
201.16 ME SYSTEMS . 18
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 18
202 Electromagnetic disturbances – Requirements and tests . 18
206 Usability . 19
211 Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS
used in the HOME HEALTHCARE ENVIRONMENT . 19
Annexes . 20
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 21
Annex D (informative) Symbols on marking . 24
Annex AA (informative) Particular guidance and rationale . 25
Annex BB (informative) Protective eyewear for HOME LIGHT THERAPY EQUIPMENT . 28
Bibliography . 29
Index of defined terms used in this particular standard . 30
Table 201.101 – EMISSION LIMITS for risk groups of HOME LIGHT THERAPY EQUIPMENT . 11
Table 201.102 – Time criteria for risk groups of HOME LIGHT THERAPY EQUIPMENT . 12
Table 201.103 – Applicable ANGLE OF ACCEPTANCE for the assessment of emitted
OPTICAL RADIATION from HOME LIGHT THERAPY EQUIPMENT . 12
Table 201.C.101 – Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts . 21
Table 201.C.102 –Safety signs per HAZARD and per risk group . 22
Table 201.C.103 – ACCOMPANYING DOCUMENTS, instructions for use . 22
Table 201.C.104 –Caution statements per HAZARD and per risk group . 23
Table 201.D.1 – General symbols . 24
Table 201.D.2 – Safety signs . 24
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-83: Particular requirements for the basic safety and
essential performance of home light therapy equipment
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as "IEC
Publication(s)"). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
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between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
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5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
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6) All users should ensure that they have the latest edition of this publication.
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8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 60601-2-83 has been prepared by IEC subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
The text of this International Standard is based on the following documents:
FDIS Report on vot
...
IEC 60601-2-83 ®
Edition 1.1 2022-12
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-83: Particular requirements for the basic safety and essential performance
of home light therapy equipment
Appareils électromédicaux –
Partie 2-83: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de luminothérapie à domicile
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.
Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite
ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie
et les microfilms, sans l'accord écrit de l'IEC ou du Comité national de l'IEC du pays du demandeur. Si vous avez des
questions sur le copyright de l'IEC ou si vous désirez obtenir des droits supplémentaires sur cette publication, utilisez
les coordonnées ci-après ou contactez le Comité national de l'IEC de votre pays de résidence.
IEC Secretariat Tel.: +41 22 919 02 11
3, rue de Varembé info@iec.ch
CH-1211 Geneva 20 www.iec.ch
Switzerland
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.
About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigendum or an amendment might have been published.
IEC publications search - webstore.iec.ch/advsearchform IEC Products & Services Portal - products.iec.ch
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Stay up to date on all new IEC publications. Just Published
containing more than 22 300 terminological entries in English
details all new publications released. Available online and
and French, with equivalent terms in 19 additional languages.
once a month by email.
Also known as the International Electrotechnical Vocabulary
(IEV) online.
IEC Customer Service Centre - webstore.iec.ch/csc
If you wish to give us your feedback on this publication or
need further assistance, please contact the Customer Service
Centre: sales@iec.ch.
A propos de l'IEC
La Commission Electrotechnique Internationale (IEC) est la première organisation mondiale qui élabore et publie des
Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.
A propos des publications IEC
Le contenu technique des publications IEC est constamment revu. Veuillez vous assurer que vous possédez l’édition la
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monde, avec plus de 22 300 articles terminologiques en
Published détaille les nouvelles publications parues.
anglais et en français, ainsi que les termes équivalents dans
Disponible en ligne et une fois par mois par email.
19 langues additionnelles. Egalement appelé Vocabulaire
Electrotechnique International (IEV) en ligne.
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Si vous désirez nous donner des commentaires sur cette
publication ou si vous avez des questions contactez-nous:
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IEC 60601-2-83 ®
Edition 1.1 2022-12
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-83: Particular requirements for the basic safety and essential
performance of home light therapy equipment
Appareils électromédicaux –
Partie 2-83: Exigences particulières pour la sécurité de base et les
performances essentielles des appareils de luminothérapie à domicile
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.60 ISBN 978-2-8322-6308-2
IEC 60601-2-83 ®
Edition 1.1 2022-12
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
Medical electrical equipment –
Part 2-83: Particular requirements for the basic safety and essential performance
of home light therapy equipment
Appareils électromédicaux –
Partie 2-83: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de luminothérapie à domicile
– 2 – IEC 60601-2-83:2019+AMD1:2022 CSV
© IEC 2022
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
INTRODUCTION to Amendment 1 . 7
201.1 Scope, object and related standards . 9
201.2 Normative references . 10
201.3 Terms and definitions . 11
201.4 General requirements . 13
201.5 General requirements for testing ME EQUIPMENT . 13
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 13
201.7 ME EQUIPMENT identification, marking and documents . 15
201.8 Protection against electrical HAZARDS from ME EQUIPMENT. 18
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 18
201.10 Protection against unwanted and excessive radiation HAZARDS . 18
201.11 Protection against excessive temperatures and other HAZARDS . 21
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 21
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 21
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 21
201.15 Construction of ME EQUIPMENT . 21
201.16 ME SYSTEMS . 21
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 21
202 Electromagnetic disturbances – Requirements and tests . 21
206 Usability . 22
211 Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL
SYSTEMS used in the HOME HEALTHCARE ENVIRONMENT . 22
Annexes . 24
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 25
Annex D (informative) Symbols on marking . 28
Annex AA (informative) Particular guidance and rationale . 29
Annex BB (informative) Protective eyewear for HOME LIGHT THERAPY EQUIPMENT . 32
Bibliography . 33
Index of defined terms used in this particular standard . 34
Table 201.101 – EMISSION LIMITS for risk groups of HOME LIGHT THERAPY EQUIPMENT . 14
Table 201.102 – Time criteria for risk groups of HOME LIGHT THERAPY EQUIPMENT . 15
Table 201.103 – Applicable ANGLE OF ACCEPTANCE for the assessment of emitted
OPTICAL RADIATION from HOME LIGHT THERAPY EQUIPMENT . 15
Table 201.C.101 – Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts . 25
Table 201.C.102 – Safety signs SAFETY SIGNS per HAZARD and per risk group . 26
Table 201.C.103 – ACCOMPANYING DOCUMENTS, instructions for use . 26
Table 201.C.104 –Caution statements per HAZARD and per risk group . 27
© IEC 2022
Table 201.D.1 – General symbols . 28
Table 201.D.2 – Safety signs SAFETY SIGNS . 28
– 4 – IEC 60601-2-83:2019+AMD1:2022 CSV
© IEC 2022
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-83: Particular requirements for the basic safety and
essential performance of home light therapy equipment
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as "IEC
Publication(s)"). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in t
...
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